CHICAGO, Illinois, September 27, 2012 – A recent study of Industry success rates shows that for most – but not all – phases of Development, large molecule success rates continue to be higher than that of small molecules. In Phase 2, for example, large molecules have a 44% success rate, compared to 18% for small molecules. In the final Registration phase, large molecules attained only a 79% success rate whereas small molecules achieved 85%.
This analysis is based on detailed data from the Pharmaceutical Benchmarking Forum (PBF) -- which consists of the leading pharmaceutical companies. It covers all therapy areas and examines industry performance over the most recent 5 years.
“Given the changing portfolio at large biopharma companies, the difference between large and small molecule success rates is of high interest to the Industry,” according to Linda Martin of KMR Group, the firm facilitating the analysis. “We have seen some convergence of rates by molecule size, but for now at least there remains an important difference, with overall large molecule success rates in Development still substantially higher than those of small molecules.”
Founded in 1997, the PBF is the Industry’s premier source for R&D analytics. In 2012 the following submitted data for this analysis: Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck Research Labs, Novartis, Novo Nordisk, Pfizer, Roche, and Sanofi. The PBF examines performance in focused areas within R&D as well, such as this fall’s detailed study of the cost of Drug Development projects.
Percent calculated to achieve 1 Approval for small molecules: apply multiplier method for each phase for small molecules (e.g., Phase 2 rate starts with industry portrait Phase 2 success rate and multiplies all subsequent phase success rates to obtain 9%); “portrait” means all Industry data treated as a single company.
“Small” refers to chemical molecules; “Large” refers to biologics (including peptides); vaccines are excluded; “Industry Portrait” means all data from contributing companies is combined into single analysis (as if they were a single company)
Pure method employed: for given molecule size, all in-licensed/acquired NMEs excluded from calculation for the phase in which they entered, but included for all subsequent phases
Method to calculate Success Rate: (number of small molecule successes in phase) / ((number of small molecule terminations in phase) + (number of small molecule successes in phase)); same method applied for large molecules
About Pharmaceutical Benchmarking Forum
Formed in 1997, the Pharmaceutical Benchmarking Forum (PBF) consists of many of the world’s leading pharmaceutical companies and has emerged as the Industry’s premier source on R&D performance metrics. Its focus is to employ careful analysis of R&D data to compare performance, examine Industry trends, answer critical business questions, and identify best practices. The scope of the Forum extends across the full R&D spectrum, from a detailed examination of Discovery to an annual review of R&D performance, including productivity, success rates, cycle time, and pipeline. In addition to its flagship study on R&D performance, the PBF sponsors additional studies on topics of interest to the Industry. These specialist studies range from the evaluation of project cost to an in-depth look at biologics R&D.
KMR has been working exclusively in the biopharmaceutical R&D industry since the early 1990s. KMR is a leader in benchmarking, analytics and performance management as well as a developer of proprietary analytics software. With an exclusive focus on biopharmaceutical R&D and unrivaled commitment to data quality, KMR provides industry with the experience and knowledge to produce clear and uncompromising results in the form of reports, tools and presentations. We use our extensive, unparalleled datasets and experience within the industry to add value to the most pressing business questions. Please visit our website at https://kmrgroup.com